60 Degrees Pharmaceuticals Announces All Patients Cured of Babesiosis After Tafenoquine Treatment in Expanded Use Clinical Trial

Rhea-AI Summary

60 Degrees Pharmaceuticals (NASDAQ: SXTP) reported that all three patients in its expanded‑use trial of tafenoquine for relapsing babesiosis in immunosuppressed patients achieved cure after completing the regimen.

The open‑label study used weekly tafenoquine added to atovaquone‑containing combinations sustained until two consecutive negative PCRs; combined data with a 2024 Yale report suggest near 100% cure in seven patients. Tafenoquine is not FDA‑approved for babesiosis and is approved in the U.S. for malaria prophylaxis as ARAKODA.

Positive

• All three trial patients achieved cure after tafenoquine‑containing regimens
• Combined dataset (7 patients) suggests near 100% cure when tafenoquine is added
• Use of an FDA‑approved RNA amplification blood screening test validated non‑reactive results

Negative

• Tafenoquine is not FDA‑approved for babesiosis treatment, limiting immediate labeled use
• Small sample size: combined evidence covers only seven patients, constraining statistical certainty

News Market Reaction – SXTP

+71.28% 1065.6x vol

69 alerts

+71.28% News Effect

+59.1% Peak in 8 hr 1 min

+$2M Valuation Impact

$4M Market Cap

1065.6x Rel. Volume

On the day this news was published, SXTP gained 71.28%, reflecting a significant positive market reaction. Argus tracked a peak move of +59.1% during that session. Our momentum scanner triggered 69 alerts that day, indicating high trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $4M at that time. Trading volume was exceptionally heavy at 1065.6x the daily average, suggesting very strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients cured: 3 of 3 patients Treatment duration: Up to one year Follow-up window: 60–90 days +5 more

8 metrics

Patients cured 3 of 3 patients Expanded access trial for relapsing babesiosis in immunosuppressed patients

Treatment duration Up to one year Tafenoquine regimen continued until two negative PCR tests

Follow-up window 60–90 days Post‑resolution follow‑up after stopping study drug

Test sensitivity 1,000 times more sensitive FDA‑approved RNA amplification test vs standard RT‑PCR

Yale success rate 100 percent Four patients on atovaquone regimen plus weekly tafenoquine

Yale cured patients 4 patients Apparent treatment success with combination including tafenoquine

Combined patients 7 patients Yale plus company study used to assess cure rate

Negative PCR requirement Two consecutive tests Criterion for stopping tafenoquine and defining cure

Market Reality Check

Price: $3.22 Vol: Volume 61,318 vs 20-day a...

normal vol

$3.22 Last Close

Volume Volume 61,318 vs 20-day average 44,720 ahead of this clinical update. normal

Technical Shares at $1.88 are trading below the 200-day MA of $5.42 and far under the $17.68 52-week high.

Peers on Argus

Momentum scanner shows mixed moves among biotech peers, with some names up and o...

2 Up 1 Down

Momentum scanner shows mixed moves among biotech peers, with some names up and others down, suggesting this babesiosis trial update is more stock-specific than sector-driven.

Previous Clinical trial Reports

5 past events · Latest: Oct 09 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Oct 09	Trial naming update	Positive	+5.5%	Named B-FREE Phase 2 chronic babesiosis study with 12‑month timeline.
Aug 19	Site selection	Positive	-1.5%	Chose Mount Sinai as central Phase II site and outlined trial design.
Jan 28	IRB approval	Positive	-11.0%	Received IRB approval for Phase II tafenoquine study in chronic babesiosis.
Jan 08	Expanded access start	Positive	-22.1%	Initiated expanded access study for persistent babesiosis after prior failures.
Dec 11	Trial expansion	Positive	+13.3%	Expanded tafenoquine babesiosis trial to Brigham and Women’s Hospital.

Pattern Detected

Clinical trial updates for tafenoquine have often been positive but produced mixed to negative next-day price reactions, with more divergence than alignment.

Recent Company History

Over the past year, SXTP has steadily advanced tafenoquine for babesiosis, moving from IRB approval and trial site selection to enrollment and trial expansion at major centers. Five tagged clinical trial releases since Dec 2024 highlighted a growing program and large addressable market, yet next-day stock moves averaged about -3.18%. Today’s report of all three expanded-access patients being cured adds to this clinical narrative within a historically volatile trading backdrop.

Historical Comparison

-3.2% avg move · Past 5 tafenoquine clinical‑trial headlines saw an average next‑day move of -3.18%, showing that eve...

clinical trial

-3.2%

Average Historical Move clinical trial

Past 5 tafenoquine clinical‑trial headlines saw an average next‑day move of -3.18%, showing that even constructive data often coincided with pressure on SXTP shares.

Clinical news has progressed from IRB approval and site selection to enrollment, multi‑center expansion, and now patient‑level cure data in babesiosis, marking a steady program build‑out.

Market Pulse Summary

The stock surged +71.3% in the session following this news. A strong positive reaction aligns with t...

Analysis

The stock surged +71.3% in the session following this news. A strong positive reaction aligns with the clearly favorable clinical signal, with 3/3 patients cured and supportive Yale data across 7 total cases. However, prior tafenoquine trial headlines averaged about -3.18% next‑day moves, showing the stock has often faded good news. Investors would need to weigh this history, ongoing ATM capacity from recent filings, and small‑cap volatility when assessing how durable any upside might be.

Key Terms

babesiosis, expanded access, open-label, pcr, +4 more

8 terms

babesiosis medical

"All three patients enrolled in study have been cured of babesiosis..."

Babesiosis is an infection caused by microscopic parasites that invade and destroy red blood cells, most commonly spread by tick bites or contaminated blood transfusions. It matters to investors because outbreaks, new diagnostic tests, treatments or vaccines, and changes in blood-screening rules can alter demand and regulatory risk for healthcare and agricultural companies — similar to how a food-safety scare can force recalls, new procedures, and unexpected costs that move stock prices.

expanded access regulatory

"The Company’s expanded use trial is an open-label, expanded access, multi-site study..."

Access that lets patients use an experimental drug or medical device outside of a formal clinical trial when no approved options are available. Think of it like allowing someone to test-drive a prototype car because they have no other transportation; for investors, expanded access can affect short-term demand, provide additional safety or usage information, and carry reputational or regulatory risks that may influence a company’s prospects and potential future sales.

open-label medical

"The Company’s expanded use trial is an open-label, expanded access, multi-site study..."

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

pcr medical

"until two consecutive negative PCR tests for Babesia parasites are recorded..."

PCR (polymerase chain reaction) is a laboratory method that makes many copies of a tiny piece of genetic material (DNA or RNA) so scientists can detect and study it reliably — think of photocopying a faint, tiny note until the words are easy to read. For investors, PCR matters because it underpins diagnostic tests, drug development, and biotech tools whose sales, regulatory approvals, and real-world use can materially affect company revenues and market perceptions during health events or product launches.

rt-pcr medical

"One test is an RT-PCR from Mayo Clinic."

RT-PCR is a laboratory test that converts a tiny amount of genetic material from a sample into many copies so specific viral or genetic targets can be detected, like photocopying one page until you have enough to read clearly. For investors, RT-PCR matters because its accuracy, capacity, and regulatory approval drive demand for diagnostic equipment, testing services, and related supply chains, and can influence revenue and market sentiment around healthcare and biotech companies.

rna amplification test medical

"The second is a U.S. Food and Drug Administration (FDA)-approved RNA amplification test..."

A RNA amplification test is a laboratory method that finds and multiplies traces of viral or genetic RNA so even tiny amounts become detectable, like photocopying a faint document until the words are clear. Investors care because these tests determine a diagnostics product’s sensitivity, speed, cost and regulatory acceptability, which directly affect market demand, revenue potential and the competitive position of companies that develop, manufacture or use them.

fda-approved regulatory

"The second is a U.S. Food and Drug Administration (FDA)-approved RNA amplification test..."

FDA-approved means a medical product, drug, device or treatment has passed the U.S. Food and Drug Administration’s review for safety and effectiveness for a specific use. Think of it like a formal safety and performance seal that allows the product to be marketed for that purpose in the U.S.; for investors, approval reduces regulatory uncertainty, enables sales and reimbursement pathways, and can materially affect a company’s revenue prospects and valuation.

malaria prophylaxis medical

"Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA..."

Malaria prophylaxis is the use of medications or preventive measures to stop malaria infection before or during exposure, similar to carrying an umbrella to avoid getting wet in a storm. For investors, prophylaxis matters because it drives demand for drugs, influences regulatory review and approval pathways, affects manufacturing and supply chains, and shapes market size and revenue forecasts for companies developing or selling preventive treatments.

AI-generated analysis. Not financial advice.

• All three patients enrolled in study have been cured, confirming high cure rate of tafenoquine in immunosuppressed patients, as reported by Yale in a 2024 publication
• Company calls for existing babesiosis treatment guidelines to be reviewed in light of the new data

WASHINGTON, March 11, 2026 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, today announced that three of three enrolled patients have been cured of babesiosis after completing the tafenoquine regimen in the Company’s trial of relapsing babesiosis in immunosuppressed patients.

The Company’s expanded use trial is an open-label, expanded access, multi-site study evaluating the safety and efficacy of the ARAKODA^® regimen of tafenoquine combined with atovaquone and other antimalarials/antibiotics administered to patients with risk factors for severe disease with relapsing babesiosis who have previously failed conventional antimicrobial regimens (NCT06478641). It aims to confirm the high cure rate from the addition of tafenoquine in these patients, as reported by the Yale School of Public Health in a 2024 Clinical Infectious Diseases publication.

For this study, tafenoquine treatment is continued for up to one year until two consecutive negative PCR tests for Babesia parasites are recorded and symptoms of babesiosis are resolved. Sixty to ninety days following clinical resolution and cessation of study drug administration, the study protocol calls for a follow-up visit at which two molecular tests are administered to assess parasite infection status. One test is an RT-PCR from Mayo Clinic. The second is a U.S. Food and Drug Administration (FDA)-approved RNA amplification test used for blood donation screening that is at least 1,000 times more sensitive than standard commercial RT-PCRs such as the Mayo test. A patient is considered cured if no evidence of infection (i.e., a non-reactive RNA amplification test) is detected following treatment.

The Yale study reported an apparent treatment success rate of 100 percent in four patients when an atovaquone-containing standard of care regimen was combined with weekly tafenoquine administered until two sequential non-reactive conventional PCRs were noted. The fifth patient in the Yale study was administered weekly tafenoquine monotherapy, then azithromycin/atovaquone; the triple regimen was not sustained until consecutive negative PCRs were noted, and so was not successful.

That same final patient in the Yale study was the third patient in the Company’s expanded access study, and a quadruple combination of atovaquone/azithromycin/proguanil and weekly tafenoquine sustained until two negative PCRs were noted was ultimately curative as demonstrated through a non-reactive RNA amplification test following treatment. Cure was achieved with a triple combination of tafenoquine, atovaquone, and an antibiotic for the first two patients enrolled in the study. 

Collectively, in the seven patients evaluated (the Yale study and the Company’s study, combined), the data suggest that the cure rate for relapsing babesiosis in immunosuppressed patients approaches 100 percent when weekly tafenoquine is added to a patient’s background atovaquone-containing combination regimen and sustained until two negative PCRs are noted.

Given the rarity of relapsing immunosuppressed patients and the high cure rate associated with adding tafenoquine, the Company believes it is an appropriate time for widely accepted treatment guidelines to be reviewed in light of the new data.

Human babesiosis is a serious and debilitating emerging tick-borne illness often found as a co-infection in patients with Lyme disease. Symptoms include fevers, chills, sweats, and fatigue. Babesiosis can be life-threatening in elderly and immunosuppressed patients, relapsing multiple times. Incidence of the disease is rising.

No FDA-approved treatment or vaccine exists for babesiosis.

Tafenoquine is not currently approved by the FDA for the treatment and prevention of babesiosis. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA^® (tafenoquine).

About ARAKODA^® (tafenoquine)
Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA^® and in Australia as KODATEF^®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, offers the advantage of less frequent dosing for the prophylaxis of malaria. ARAKODA^® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA^® 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.

ARAKODA^® (tafenoquine) Important Safety Information
ARAKODA^® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.

Contraindications
ARAKODA^® should not be administered to:

• Glucose-6-phosphate dehydrogenase (“G6PD”) deficiency or unknown G6PD status;
• Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if
• G6PD status is unknown;
• Patients with a history of psychotic disorders or current psychotic symptoms; or
• Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA^®.
  
  

Warnings and Precautions
Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA^® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.

G6PD Deficiency in Pregnancy or Lactation: ARAKODA^® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA^® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA^® through breast milk. Check infant’s G6PD status before breastfeeding begins.

Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.

Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA^® therapy and evaluation by a mental health professional as soon as possible.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA^®. If hypersensitivity reactions occur, institute appropriate therapy.

Delayed Adverse Reactions: Due to the long half-life of ARAKODA^® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.

Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety.

Drug Interactions
Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.

Use in Specific Populations
Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA^®. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODA^® is located here.

About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of its lead product, ARAKODA^® (tafenoquine), for malaria prevention, in 2018. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a subsidiary in Australia. Learn more at www.60degreespharma.com.

The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.

Cautionary Note Regarding Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA^® or other regimen) or Australian Chestnut Extract in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Media Contacts:

Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com 
(484) 667-6330     

Investor Contact
Patrick Gaynes
patrickgaynes@60degreespharma.com

FAQ

What were the results of 60 Degrees Pharmaceuticals' March 11, 2026 tafenoquine trial for babesiosis (SXTP)?

All three patients in the company's expanded‑use trial were cured after completing tafenoquine‑containing regimens. According to 60 Degrees, results combined with a Yale 2024 report bring the total to seven patients with an apparent near‑100% cure when weekly tafenoquine is added to atovaquone regimens.

How does 60 Degrees define "cure" in the SXTP expanded‑use babesiosis study?

Cure is defined by two consecutive non‑reactive molecular tests after stopping therapy and symptom resolution. According to 60 Degrees, one test is Mayo Clinic RT‑PCR and the other is an FDA‑approved RNA amplification test deemed ~1,000× more sensitive than standard RT‑PCRs.

Is tafenoquine approved by the FDA to treat babesiosis as of March 11, 2026 (SXTP)?

No, tafenoquine is not FDA‑approved for babesiosis treatment. According to 60 Degrees, tafenoquine is approved in the U.S. only for malaria prophylaxis under the name ARAKODA, and use for babesiosis remains off‑label or investigational.

What regimen produced cures in the SXTP expanded‑use study for relapsing babesiosis?

Cures occurred when weekly tafenoquine was added to atovaquone‑containing combination therapy and sustained until two negative PCRs. According to 60 Degrees, combinations used included atovaquone with antibiotics and, in one case, a quadruple regimen that achieved a non‑reactive RNA amplification test.

Will 60 Degrees seek changes to babesiosis treatment guidelines after the SXTP trial results?

The company says the new data warrant a review of existing treatment guidelines for relapsing immunosuppressed patients. According to 60 Degrees, the rarity of such cases combined with high cure rates supports reconsideration of standard recommendations.